Q3 2022 Relmada Therapeutics Inc Earnings Call
Any background noise. After the Speakers' remarks, there will be a question and answer session. If you'd like to ask a question during that time simply press. The star followed by the one on your telephone keypad, if he'd like to withdraw your question again press Star one Thank you and Brian Ritchie you May begin your conference.
Thank you operator, and thank you all for joining US. This afternoon with me on today's call are Chief Executive Officer, Sergio to versa, and Chief Financial Officer, Matthew <unk>.
This afternoon <unk> issued a news release, providing a business update announcing financial results for the three and nine months ended September 32022, and filed its quarterly report on Form 10-Q with the SEC. Please note that certain information discussed on the call today is covered.
Under the Safe Harbor provisions of the private Securities Litigation Reform Act, we caution listeners during this call that real modest management team will be making forward looking statements actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties.
So sitting with the company's business. These forward looking statements are qualified by the cautionary statements contained in row modest press release issued today and the company's SEC filings, including in the annual report on Form 10-K for the year ended December 31, 2021, and subsequent filings this call.
It's call also contains time sensitive information that is accurate only as of the date of this live broadcast November 10th 2020 to.
<unk> undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call now I would like to turn the call over to Sergio Sergio.
Thank you, Brian as always and good afternoon to everyone. I am pleased to welcome you to the rollout of the third quarter of 2022 conference call.
During today's call I will provide an update on our ongoing late stage reliance clinical development program <unk> 17.
Our lead product candidates that we are currently studying as a novel treatment for patients with major depressive disorder or <unk>.
Following my comment Mega Shenouda, our Chief Financial Officer will review, our financial results and balance sheet and we will then take your questions.
As a reminder.
The last one and bromine.
Two ongoing phase III system to arm.
Placebo controlled pivotal studies evaluating well 10, 17, 25 milligrams as a potential adjunctive treatment for AMD.
Brian Street was the phase III two arm placebo controlled Registrational study evaluating <unk> 25 milligram.
As a potential monotherapy treatment for Mds.
We announced topline results last month will rely on <unk> III and <unk> 17.
For a minute administered for 28 days to 232 subjects.
The study did not achieve the primary endpoint of a statistically significant improvement in depression symptoms.
Compared to placebo as measured by the Montgomery, Asbury depression rating scale or metrics.
On day 28.
In this study the route 10 17 treatment arm showed the macro reduction of $14 eight points a day 28.
Versus 13 nine points for the placebo arm.
This wasn't higher than expected placebo response.
But I'd obstacle results, we observed observed in certain study sites were placebo dramatically outperformed growth in 17.
To better understand the paradoxical result at pop up exploratory analyses.
Using the bandpass method, which exclude sites and blogs as deeply high or low lets people responsible conduct.
In this study.
Implausibly high or low placebo response was defined as a mean decrease from baseline in Madras 10 score greater than 14 analyzed and people.
<unk>.
The result of the band personnel as it showed a meaningful difference between <unk> 17 and placebo.
Greater than four nine points on the module, representing a P value below 0.05.
It is important to note.
While we are pleased.
We the statistically significant difference seeing using the bandpass method, we understand that this is not sufficient to be used as an FDA submission.
And we May consider planning additional studies.
I want to highlight that in reliance III, rather than 17 demonstrated very favorable tolerability and safety confirming the results of phase one and phase two studies.
No opioid like effect no withdrawal effects and most type of something they take effect.
Okay.
While we are currently further evaluating the data from over the last week, we believe that the primary driver behind this study not being successful was the enrollment of subjects, who are not truly suffering from MDT and responded dramatically and rapidly to placebo.
As an example of this the top enrolling center.
The mean change from baseline of 23 points in the placebo group.
As we approach the top line readout for reliance one <unk>.
Expected before year end it is important to note that.
So the high enrolling centers in rather than rely on <unk> III also recruited significantly in reliance one.
Mitigating that to some degree.
Is.
The different patient population reliance one.
These patients that enrolled.
And she was already been diagnosed with depression and Theyre not responding adequately.
Adequately go at least one and up to three courses of antidepressants.
We cannot predict how these factor we balance out.
Looking further ahead, we intend to apply several protocol and operational changes in the current enrolling rollouts to study and make certain improvement to how the trial is being conducted.
We now expect top line results from this study next year.
Once we have finalized and determining how to best execute on these enrollment we will provide a firm timeline for top line results for alliance.
Yeah.
Moreover.
In order to be proactive and increase the likelihood of clinical success for <unk> as a potential therapy for MTBE and indication in which two successful studies are required to achieve approval. We may consider initiating new clinical trials in 2023.
As we apply key learnings from the last three to improve how reliance who is being conducted going forward. We are focused on the four key pillars that mainly impact the success of an mbd trial.
<unk>.
Site selection.
Patient selection and the rating process.
We will integrate our key learnings in this area into the alliance to study and any possible additional study will make us.
Now, let's move on to reliance oil as the long term open label safety study that is enrolling both rollover participants for all three pivotal studies.
As well as dinner parties with them.
Realized oil is ongoing and continues to enroll a participant as planned.
Data from these long term open label safety study, which we now expect from first half of 2023 will be part of the planned NDA filing package.
Finally.
I want to emphasize that relentlessly was a trial execution phase.
We remain highly confident in the potential residents and it seems to be a safe and effective new therapy for the treatment of mbd.
It is important to note that we have the financial flexibility to continue advair.
Advised advancing present 17, indicating due to our strong balance sheet magnet will review our financials in detail shortly.
We ended the third quarterly cash cash equivalent and short term investments of approximately $124 million.
With that I will now turn the call over to Maggie for his review of the financials.
Pages York sure.
Thank you Sergio today, we issued a press release announcing our business and financial results for the three and nine months ended September 32022, which I will now review.
Third quarter ended September 32022, total research and development expense was approximately $35 million as compared to $34 million for the comparable period of two.
2021, the decrease was primarily related to a decrease in stock based compensation. This noncash charge totaled $3 2 million in the most recently completed third quarter.
Total general and administrative expense for the third quarter ended September 32022 was approximately $8 2 million as compared to $8 $7 million for the comparable period of 2021, a decrease of approximately <unk> 5 million. The decrease was primarily driven by a decrease in stock based compensation.
This noncash charge totaled $5 2 million in the most recently completed third quarter.
For the third quarter ended September 32022, net loss was $39 4 million or.
A $1 31 per basic and diluted share compared to a net loss of $42 6 million or $2 44 per basic and diluted share in the comparable period of 2021.
The results for the nine months ended September 32022, total research and development expense was approximately $86 $5 million.
Impaired to $65 3 million for the comparable period of 2021.
The increase was primarily related to an increase in costs associated with the execution of a broader clinical program for <unk> 17.
For the nine months ended September 32022, total general and administrative expense was approximately $36 1 million as compared to $26 2 million for the comparable period of 2021. The increase was primarily driven by an increase in stock based compensation.
For the nine months ended September 32022, net loss was approximately $119 1 million or $4.04 per basic and diluted share compared to a net loss of $91 4 million or $5 36.
Our basic and diluted share in the comparable period of 2021.
As of September 32022, we had cash cash equivalents and short term investments of approximately $184 $2 million.
Compared to cash cash equivalents and short term investments of approximately $211 9 million at December 31, 2021, as Sergio mentioned, our current cash position provides us with it provides us with ample runway.
We're approximately two years of cash I will now turn over the call to Sergio Sergio.
Thank you Mike.
Before.
Taking your questions I would like to share that we have on the call with US today. The reliance program principle investigator Dr. Maurizio Fava chairman of Harvard's Casualty Department that can answer the question regarding the relative in 17 clinical development. Thank you Mauricio for Jordan.
With that I will.
With that I will ask the operator to open the call for questions.
Thank you.
This time I would like to remind everyone in order to ask a question. Please press. The star then the number one on your telephone keypad, we'll pause for just a moment to compile the Q&A roster.
And first we will go to market Goodman of SBB Securities.
Thanks for taking my question is really on a LIFO mark.
So reliance.
One tenant SKU expected your first quarter I'm wondering if you're making any changes to this study.
What are your current plans do with study sites placebo outperformed the drug and did you talk with FDA together agreements, where your data analysis. Thanks.
Thank you for your question.
Well the reliance one treaty.
<unk> done we are planning to close the database.
And the next two or three weeks. So we are we expect to have data before the end of the ESR, It's way too late to make any changes.
No.
Notice in the.
The opening remark.
There is some difference there.
Two factors and reliance one that could make a difference one is that the patient population is different. So these are patients not naive not mono therapy. The patient had been proposed to be diagnosed with depression that have been taken at least one treatment.
At least six weeks and they have not responded.
So in <unk>.
Ethically and adult profile are going to help us out on this topic, but youre ready to go to these patients who respond less.
Two two placebo at the <unk>.
Site, the site and that the.
Operational issues they are affected.
I have three art present, especially at the sites that enrolled.
Yes.
Large parts of it.
Patients.
I'll also rolled and realized one thing we don't know how these two factor wasn't even favor yes.
The other one may not be in favor of holiday.
But it's way too late to make any changes we want to see what the results will look like.
And sorry can you repeat the second part of your question.
Yes, just wondering.
What's your current plan for data analysis, it's going to be the same for relaunch.
Your lines.
Yes.
Okay.
They provide the impacts but the.
<unk> is a very good.
Diagnostic tool and because you have the product works or not but.
So we think that the primary analysis will be the same as what I and III with full coverage.
Got it.
Thank you.
Thank you.
Yeah.
And next we'll take a question from <unk>.
Hum.
Okay.
Hi, guys. Thanks for taking my question.
Just wanted to get a better understanding of.
The I guess the.
Diagnostic tool the tool that was used to access.
The incoming patients him reliance three.
Whether the.
The tool captured some patients who.
Our.
Been chronically depressed or.
Our episodically depressed town mandate, they've not really establish sort of like a.
Persistent stage of depression.
So that's my first question and then I guess my second question is.
And the lion's one I think you said the study if it stopped and could you tell us whether you enroll the expected number of patients and what are the DSM b.
As you too.
To stop enrollment or is it.
You think it's sufficiently powered just wanted to get a better sense of what's going on there. Thanks.
Thanks for the question Duffy.
Dr Fava.
The first one is can you help us out the last one analyze these data. So please go ahead, Sir I will then ask the second question.
Please go ahead.
So it's a great question.
Maurizio fava achievements of country mass mass general.
The principal investigator for this.
The studies.
Ed.
One of the characteristics of.
The monotherapy trial was that patients had to be.
Medicines, so they had to be typically a treatment naive never treated during the current episode.
And.
And in addition.
There had to be relatively lean for U S. Standards. There is they have to have a BMI between 18 and 30.
No.
And we know for example that chronic recurrent depression is associated with weight gain.
The people.
<unk>.
In the thirties.
So I.
I think that.
Yeah.
The combination of the pandemic.
Pandemic, causing stress induced depressive episodes.
Individuals, whom.
Do not have a prior history of depression.
This led to a number of individuals.
Seeking treatment from study because they were having.
Having trouble accessing treatment because they were not in treatment.
If you wish.
Before.
And and.
As we see often stress induced depressive episodes.
Have a high probability of spontaneous remissions, they get better on their own.
But if they get better on their own they kept the bedroom.
Better on placebo as well.
And.
The 301 study.
We have patients who.
That has to be on antidepressants have to have failed to respond to the questions. They have to be in treatment with the psychiatrists.
And so they're very likely to have.
Recurrent forms of depression, so more.
Bonafide.
Conditions medical condition.
Yeah.
The challenge is that according to our DSM five classification.
The personal develops depressive symptoms acutely.
It meets that criteria exact before a major depressive episode exactly as someone who has had recurrent episode or chronic symptoms.
So when we designed the monotherapy study we did not factor in there.
The impact of.
Of the pandemic on kind of the diagnosis of depression in the general population.
I can tell you is it.
You guys are my general we've seen a tripling of their referrals for anxiety and depression to our department.
And we've seen nationally in the PD Lone So studies that we've seen a tripling of our science in depression. So.
Are these diseases.
We're seeing this rise of people experiencing depression or R&D as you know.
Stress related.
Sure.
Depressive episodes that in some ways was container is resolved.
The answer we don't know the answer but it clearly affected our monotherapy trial.
In my opinion this should not.
The issue in patients who have been.
Uh huh.
Under treatment with the psychiatry is not.
Not responded to treatment.
<unk> is a protein.
Containers are emissions.
Very very small in that population compared to patients.
Never treated first step so.
Sure.
Yeah.
Caused by the pandemic.
Okay.
Thank you Marty.
Total product and.
Hope that answer your question and.
The second part of the question.
The number of patients the number of patient was a valuable up to 350 patients than 60, the SMB recommended to stop the trial at the minimum number two.
'twenty, we exceeded a little bit better.
But we're exceeding a little bit better, but don't read anything into that because it.
The data monitoring committee.
They have made a recommendation for two reasons the trial.
It's futile so.
Not worth it.
Proceed and add more patient that it would never be statistically significant for the trial is already statistically significant at the $2 20 number so I mean, what the SMB recommended it doesn't mean anything in terms of results.
No way to read it because the trial will be successful or the trial will not be successful.
Yeah.
Okay to answer the second part of your question.
Yeah. Thank you very much.
Yeah.
Yeah.
Our next week on <unk>. Thank you.
Okay.
Hey, guys just a couple of questions for me just to clarify it.
What percent or how many of the sides that but in the monotherapy study are going to be overlapping in the lines one.
I think previously when we had discussions with you would seem to imply that there is a possibility of increasing the sample size.
If the study is still not done yet why not increase the size in order to be statistically significant.
Yeah.
Yes, well thank you Cathy.
Quick question.
The in terms of overlapping of size I don't have the exact number but there is the vast I would say the overlapping is pretty high.
<unk> monotherapy and rely on swap.
The one that really matters.
Might that have a high.
The enrolled a lot of patient the high enrolling sites and they are the one that have this paradoxical response with placebo.
<unk> outperformed the broader by quite a bit.
And it's kind of isolated to a few sites. So these are the ones that really could make the difference we don't know.
The fact, the site or any reliance one as well, but we don't know the phenomena is good.
Going to be the same or not as Paolo was saying this is a different patient population.
These sites may have different results, but we won't know until we see it and.
We discuss about expanding the enrollment in the <unk>.
Last one.
Would it be SMB recommendation.
If the site.
The trial.
Is somewhat compromised.
Adding more patients will just yes.
Spend time cost and probably unless we tripled doubled the number of patients won't make a big difference. So it's much more productive.
See how the results look like learn from their results and eventually will likely start new at least one.
Trial and from scratch.
Applying all what we have learned from the mono therapy, and what we will learn from the.
Last one so the decision was really just let's see how the data look like is the profile of the patient.
It's different.
Got it and then Doug.
Reliance <unk> is the other lines to already ongoing or that one is also on pause given that you wanted to see water lines. One is it going to yield.
But clearly realized however, as one will look like it will have an impact on reliance to four now we are just implementing quite a bit of changes from the protocol to limiting the number of patients per site. So in changing the way.
The rating is done from.
From a localized to most likely a lot less localized rating. So we are implementing these changes, but yes technically the trial is open they only enroll 25% roughly of the full patient population. So it really has two is still a very valuable trial the site and the similarity.
With the alliance one and three the size that they are effective or last three theyre not.
And so that that's already an indication of the number of patients. So that's a perfectly.
Non we don't think is a compromise study that will continue to enroll and we expect to complete and have data sometime next year probably.
Yeah.
Yeah.
I hope I answered your question.
Okay.
And we'll move to our next caller and that will be Andrea <unk> of Goldman Sachs.
Thanks for taking my question.
Sandra.
Hi.
Maybe one follow up there just wondering if you've been able to understand more what happened at the sites, where you can observe the paradox call results.
Anything in particular that they may have been doing differently on steady execution.
On the other side do you think additional training as may be necessary.
As you look to these improvements that you were speaking about for reliance.
Yes, I will let Doug or pilot two to answer that question from my perspective, clearly additional trading and these needed for these sites and then faster enrollment this site.
<unk> debt.
We call them commercial sides, but they enroll patient theres a base of their business. So they are not hospitals or clinics or so there are fewer like are they the size of the enrolled patients for clinical trial and pretty much all the patients that enrolled there had been enrolled coming from social media advertising so right.
When you roll out a patient can go wrong.
And.
Some time.
The diagnosis is down a little bit on the on the upside, but I like the profile of these via the experts of this for one more in detail later.
Yes, great.
Great question I think that.
Okay.
Serve.
Sure than necessarily.
That.
The full to was India assessment.
Again, we need to consider the population that we were trying to enroll.
The studies, specifically look for people untreated.
With the major in acute depressive episodes in the midst of the pandemic.
And.
Recruiting primarily to advertise.
So.
Got it.
If I am already an existing patients.
I have my Doctor if I have a recurrence of depression I go through my Doctor I go back to the medicines I've tried before and before.
But I have never been treated before.
I'll respond to an AD.
Yes.
Luca This study.
So whenever you're doing the study.
<unk>.
This is specifically looks for people who have never been treated before.
Who have developed symptoms acutely.
Don't have chronic or recurrent depression and therefore.
You don't know that.
At least in prior episodes.
Have shown.
They've responded only two medicines.
Your.
You are likely to have what we call abnormal placebo responses.
And you've gone over placebo responses are due to.
Containers formations that may have happened.
And then a point during the study.
So the.
So the same side they may have performed terribly.
By enrolling these people who.
Depression, but.
Recurrent remember, we did not ask for chronic or recurrent depression, we ask for acute.
<unk>.
Untreated patients who are not treated by antibody.
So you are looking for the best case scenario of somewhat Hu <unk>.
He is very likely.
To respond to the first therapeutic intervention that they received.
Just interacting with people getting out of.
The house during the pandemic et cetera.
Whereas in the other study, we're taking people who are in treatment.
Who are currently engaged.
Likely to have either chronic or recurrent depression, so it's like a different disease all together.
And and so.
So I don't know.
<unk>.
If I would predicted that the same size that performed badly.
Although monotherapy trial and going on to perform badly.
Mutation study because it's two different populations.
And the referral process is very different I don't know if that addresses your question Andrea.
Yeah that was that was really helpful.
Follow up there I guess.
To what extent do you believe the safer innervation, if any at all to maybe.
Maybe mitigate those issues are caught people that maybe were not appropriately enrolled in the trial or is that just the nature of the different patient populations that you are referring to that you really cant rely on this thank you.
Yes, I think thats the problem.
Okay.
I'm pretty confident that.
For the safer wood.
Clearly protect you from high placebo response rate in patients who are currently treated.
In patients who are treated.
The.
Normally you see periods of your determines what medicines to your own.
As the treatment adequate it looks the treatment history.
How many times have you been diagnosed et cetera et cetera.
The interview.
It gives us a sense of the course of illness and the confidence.
That youre dealing with the patient with a real disease.
In the monotherapy trial with an acute episode.
Question.
Theres no question about treatment because theres no treatment history.
There is no question about corn shall be on this because there is no requirement to chronic or recurrent.
And therefore.
Sure.
In a situation of high stress like the.
No.
Now at the pandemic.
COVID-19.
Even an independent interview is not going to protect you against these spontaneous remissions so.
I think that.
It's really.
The nature of the population that is very hard.
Had those patients.
Spontaneous remissions have been assigned to active treatment.
Alright, instead of the placebo in those sites.
Were they outperformed.
The placebo after so that's why the drug would have looked fantastic.
[laughter].
You often hold reclamation liberalization takes care of it but.
But the level of a given site using.
No.
Randomization will protect you against these.
Containers remissions.
Ards us with data submissions are far greater.
Our monotherapy trial.
<unk> only acute depressive episodes.
Got it Okay and then maybe one last question I can squeeze it in for you.
So Joe just wondering if you could provide more color on the additional studies that you mentioned that you think you're conducting with SB from monotherapy, specifically or is this I guess, maybe under the condition that reliance Youre Lyons wanted maybe not successful and even after.
Thank you for your trial for interim Jeff. Thanks, So much.
Yes, thank you and Hello.
Hello, again as much as they wish.
We really need we want to see your last one data resolved before and before we make any decision it.
Moving forward, we'd probably go.
Continue to go into the treatment of patients that did not respond.
Two two of treatment until the last one data.
Being part of the critical to understand how we move forward the FDA.
We believe they will want to.
Positive phase III data so yeah.
We will planning accordingly.
Correct.
Oppression.
It is not unusual to have failed study and J&J has been preoccupied pain studies in the first two project studies failed so.
It hurts me that affect directly but he is not very unusual that we would really based the plan based on the the first adjunctive trial results.
We are planning to start at least one more trial, but we will get a lot more precise.
In January after we see the things either one.
Data and we believe in December got.
Sorry for that.
It will give you all the information as soon as we have more.
Accurate plan.
To help you move forward.
Great. Thanks, everyone.
Thanks.
Okay.
And now we will move to Andrew Tsai of Jefferies.
Hi, Thanks, and good afternoon. Thanks for the questions Thats, an unfortunate to see realized for me.
The way things get better from here. So first question is for reliance three.
Outlier sites, what percentage of all patients enrolled and reliance three did these outliers sites enroll and then what percent of patients.
Those outliers sides I guess do you think albeit enrolled and reliance one unrealized here respectively.
Yeah. Thanks, Andrew for the question, a little bit difficult to answer precisely that.
The roughly the size of the head.
Results that we defined paradoxal.
Placebo outperformed the broad for whatever reason.
They enroll about between 25 and 30% of the patient and rely on.
<unk> three <unk> in the monotherapy in the first the giant team.
It's unfair to make a comparison with the same sites because its tougher palisades.
Patient population is different so this site clearly they enrolled.
30 between 30% to 40% of the patient, but the patient population is different and we don't know how these studies really performed a diagnostic.
All of the patients and it may be different but we hope it's going to be different from from monotherapy, but in terms of like.
The percent of patients wasn't between 25%, 30% in monotherapy and it's going to be between.
Mid thirties.
And then it would be a little bit more than that in the first.
And these are aligned of course, the adjunctive trial.
None of this turnaround is in in rollout too.
Okay, and then another site okay.
And so I guess, maybe a bigger picture question is is.
Sir this is unfair situation of paradoxical or results.
Is it a common occurrence and failed depression studies or is this kind of an exception data.
Covid.
Just curious what your bigger picture thoughts.
Yes, no problem.
Can you help me out on this area of the expert.
Sure.
So.
You look at our proved the presence.
Older meta analysis have shown that about.
40% of the approved antidepressants.
40% of the trials were positive.
And 60% of those studies that were positive.
Typically.
What contributed to the lack of.
Our signal detection.
As an average placebo response that was excessive.
So an analysis by again in part because the show that we have.
When you have.
Most people response rates above 40%.
Your you tend to.
Lose the ability to detect a signal.
And.
Uh huh.
However.
The.
The challenge for monotherapy trials.
But right now the current.
Stressful situations you call on them.
And that may cause situations and so forth.
Cause it.
It will inflate inflate.
The rates of depression in general population.
And if you.
We are simply looking at it.
And acute major depressive episode.
Those patients that have.
Our response to the stress do meet criteria.
So unless you specify.
Chronic recurrent depression.
In monotherapy.
Unless specified.
They'll do that.
You're more likely to have.
This is what we.
A typical spontaneous remissions.
Because of the situation we're in.
Hey, Matt.
I apologize Sergio but I have another call. It 515, so I only have three minutes left.
Thank you Sir.
I appreciate it.
And.
One last one is just the cadence of events. So it sounds like reliance one readout December .
Would you then.
Meet with the FDA to discuss whether you can make certain.
<unk> two reliance to you following reliance one.
Depending on whatever outcome that shows and then you get back to the Street and then what would be those certain improvements.
Yeah, and I think <unk>.
At this point at this time.
First of all we want to see the reliance one.
Okay.
But at this point, we don't think there is really any need to meet with the FDA.
The changes that we are actually implementing in.
Reliance two and most likely many of the trial.
Who will do more additional trials in the future. They are not the FDA, depending as really purely operational like leave me that can give you. Some example, there is few of them, but they are limiting the number of patients enrolled per site.
Right.
Sites enrolled four patients and do an audit and see how things are going to be sure that the site.
You don't perform.
The maximum level.
We probably we are making some change in the ratings.
The centralized rating may add maybe too much variability.
And we make centralize more of the rating.
There is quite a bit of luck.
The protocol.
We are simplifying the protocol rely on to any other potential trial reason being that we now have a very large amount of them.
Treated patients and safety data. So there is no need to add.
And so the.
The protocol will be more simple answer would be also easier for the sites to enroll patients now we can go on all of these but these are all operational non SBA related.
Changes.
And so nothing as a test.
And 301 is positive.
Then.
We weren't necessarily to have make.
A major operational changes to clear to them.
Okay.
Okay, and just one last clarifying is none of the outlier sites are unreliable too is that what I heard you say earlier correct correct. Okay alright.
So that would make.
I would not.
I would not really focus on co pebbles side, it's more of the current situation and we'll see our alliance one looks like it could be that these guys could have.
It performed very well in Rollouts, one so it's more or less.
The complexity of the <unk> and the diagnosis on the the kind of patient enroll that made the most of the difference. So I would not say that these are not good side. These are very reputable large sites that it does.
He is not the first at the branch on fly the abundant on many of them and so they're highly qualified.
But I would say, it's more the kind of patients.
For the monotherapy trial, there was mainly mainly responsible clearly if besides what had been limited to a single digit patient and not to 20 plus.
The impact would have been lower.
But again, we'll see what tier one looks like before we make a.
Major amendment.
Very clear okay. Thank you.
Yeah.
And now we will go to Jay Olson of Oppenheimer.
Hey, Joe.
Hey, Thanks for taking my questions.
Can you just talk about what the path forward now is to pursue.
Mono therapy MDT indication for routes in 2017.
Yes, thanks for the question Jay.
So it isn't that the facial and.
If the Doctor privacy laws I call them the help on this but it gives me an artificial.
Self create a difference between the <unk> and <unk>.
No.
So you have seen one of the competitors that we got the approval for <unk> preclinical <unk> combination of two different antidepressants and so the indication that we are pursuing is.
Treatment of patient effects the major depression.
They have not responded adequately.
Quickly to the current treatment thereon.
And then the Doctor will decide.
If it's going to be an add on or it will stop the nonperforming antidepressant replace with ground test 17, or so we're looking for more broader label.
The trial will be done.
In patients that had been not performing with the current treatment also because the diagnosis is the law.
More precise.
And there is a lot more confidence that these patients are really affected by major depression and not by personality disorder anxiety.
Similar depression can be confused with major depression.
If we if we will be successful it is going to be like a broader label treatment of the question.
Okay. Thank you that's helpful and.
And then is there any color you could provide around what percent of patients in the reliance studies at.
That opted into the open label extension.
Are they in the monotherapy.
I don't have that number on the top of my head.
Maggie.
Negative the number yes.
Okay.
Okay.
<unk>.
So broadly the numbers that we have is about 75% of the patients.
<unk> opted into Goldman.
Goldman stay open label study.
That's for all the files, though not specifically for monotherapy.
Yeah, Okay, great. Thank you that's helpful. Thanks for taking the question.
I think we have around 600 patients in the long term safety no.
Yes.
Okay.
Super helpful. Thank you.
Thank you Nick.
And now we will go to Jamie of Chester County.
Okay.
Hi, Thanks for taking my question do you have any data comparing the PK PD, a powder formulation to the tablet formulation.
That's right.
Concurrently.
Yes, Thank you Jen.
But I.
I believe the handoff from Australia, and the team they look at that.
The PK profile there is no different.
Okay.
Hey between the profile of the other end.
Gotcha.
While we have the we have the.
The powder in solution for from.
The phase II data and.
We look at the trophy.
Profile in monotherapy and the blood levels that is not good.
Okay.
And in the press release, you say that you're now expecting this results in 2023.
Is that referring to reliance tier and it's.
So it wasn't that always the case.
That you could expect that kind of thing.
Well, yes.
We don't know at this point, we would like that'd be trying not to be too specific on if it is first half second half.
We did that.
Two is about 25% enrolled but also that the focus was really really on monotherapy with with a lot of that for a lot of advertising.
And then also.
Uh huh.
Energy in completing monotherapy.
And so and then reliance once over the last two has always been.
That slowed down but not.
Not push to involve fast because we wanted to see how the other two golf. So now in 2023 <unk> two will be the focus and eventually with maybe another another phase III <unk> study that will decided after day.
One result, so we expect it shouldnt be able to complete it within 2023.
After reliance one data in December will be a lot more specifics.
Linda.
Great. Thank you so much.
Thank you John .
And that does conclude today's question and answer session I would like to turn things back. Thank you for any closing comments.
Okay.
Well. Thank you all and thank you Dr profile, I think due to the team and in closing.
I really remain grateful to the rollout of the team for their continued hard work and dedication to executing what that for US is really our mission.
And I would also like to extend sincere thanks to the participants and the clinical costs Thats involved in deep breath and 17 trial for the effort.
The advantage of this important product candidates through the clinic.
And we look forward to.
301 data and continuing to the.
The clinical development of residence in Athene, and hopefully get it approved.
At some point, thank you very much and enjoy the rest of the day.
Yeah.
And with that that does conclude today's conference call I would like to thank you again for your participation you may now disconnect.
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